European Medicines Agency Sees No Safety Concerns With The Rotarix Oral Vaccine

LONDON, March 26, 2010 -- The European Medicines Agency has
concluded that the unexpected presence of DNA of a non-disease
causing viral strain in batches of the oral vaccine Rotarix does
not present a risk to public health. At an extraordinary meeting
held on 25 March 2010, the Committee for Medicinal Products for
Human Use (CHMP) endorsed the recommendations from its Vaccines
Working Party and agreed that there was no need to restrict the use
of Rotarix.

Rotarix is a vaccine given by mouth to children of 6 weeks and
older, to protect against gastroenteritis (diarrhoea and vomiting)
due to rotavirus infection.

The DNA found in the vaccine matches that of porcine circovirus
type 1 (PCV1). This virus is commonly found in certain meat and
other food products, and is not known to cause disease in either
animals or humans. The DNA has not been found in other live
attenuated vaccines from the same manufacturer, GSK
Biologicals.

However, viral DNA should not be present in the Rotarix vaccine
and its source is unclear. The Committee has therefore requested
that the manufacturer identifies the root cause of the finding and
introduces measures to manufacture the vaccine free of PCV1
DNA.

The CHMP will be reviewing all new data on an ongoing basis. The
Committee will consider the need for further recommendations in its
meetings in April and May 2010, as further data emerges.

3. Rotarix contains a live attenuated (‘weakened’)
virus. It is prepared from live human rotavirus strains that are
manipulated to make them unable to cause the disease, while keeping
their ability to trigger an immune response.

4. Rotarix was approved in the European Union in February 2006.
It is not usually part of Member States’ childhood
vaccination schedules, but is available in all Member States. The
vaccine is widely used outside of the European Union and is part of
the World Health Organization (WHO) prequalification programme for
vaccines. Some 51,000 children received the vaccine in clinical
trials (out of a total of 91,000 children) and about 68 million
doses have been distributed worldwide to date.

5. The WHO estimates that rotaviruses are responsible for
approximately 527,000 deaths each year, with more than 85% of these
deaths occurring in low-income countries in Africa and Asia. See
here:
http://www.who.int/immunization/newsroom/news_rotavirus_vaccine_use/en/.

6. The review is being conducted in the context of a formal
review, initiated by the European Commission under Article 20 of
Regulation (EC) No 726/2004/EC. The Committee will make
recommendations on whether the marketing authorisation of Rotarix
should be maintained, changed, suspended or revoked.

7. This press release, together with other information on the
work of the European Medicines Agency, can be found on the Agency's
website: www.ema.europa.eu

Notes

1. More information on Rotarix is available in the European
public assessment report (EPAR) at
http://www.ema.europa.eu/humandocs/Humans/EPAR/rotarix/rotarix.htm.

2. See also the European Medicines Agency statement on new
information on Rotarix oral vaccine, dated 22 March 2010:
http://www.ema.europa.eu/humandocs/PDFs/EPAR/rotarix/18935010en.pdf.